PLASMAIR, MODEL T2006

K070722 · Airinspace B.V. · FRF · Dec 14, 2007 · General Hospital

Device Facts

• Record ID: K070722
• Device Name: PLASMAIR, MODEL T2006
• Applicant: Airinspace B.V.
• Product Code: FRF · General Hospital
• Decision Date: Dec 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

Indications for Use

The Plasmair Model T2006 is intended as a room air purifier/recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical cleaner. The System's dood for member of to supplement existing building air treatment and/or provide air treatment where none exists.

Device Story

Plasmair Model T2006 functions as a medical recirculating air cleaner; utilizes spatially modulated, amplified multidirectional electrostatic field technology to generate cold plasmas; cold plasma facilitates decontamination and capture of airborne particulates; device supplements existing building air treatment systems or provides air treatment in environments lacking such systems; intended for use in medical settings; operation involves air filtration and inactivation of airborne particles; benefits patient and staff by reducing airborne contaminants.

Clinical Evidence

Bench testing only. Electrical safety and performance data were provided to demonstrate that the device meets performance specifications.

Technological Characteristics

Medical recirculating air cleaner; utilizes spatially modulated, amplified multidirectional electrostatic field technology to create cold plasmas for decontamination and capture of airborne particulates; Class II device; Product Code FRF.

Indications for Use

Indicated for use as a room air purifier/recirculating air cleaner to filter and inactivate airborne particles in medical settings, supplementing existing building air treatment or providing treatment where none exists.

Regulatory Classification

Identification

A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

Predicate Devices

• MICROCON 800MUV (K972064)

Submission Summary (Full Text)

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## 510(K) Summary

K070722

### Summary of Safety and Effectiveness

| Submitted By: | Laurent Descôtes |
|-------------------------|----------------------------------------------------------|
| Date Prepared: | 11 December, 2007 |
| Trade/Proprietary Name: | Plasmair™ Model T2006 |
| Common/Usual Name: | Air Filtration System; HEPA Air Filtration System |
| Classification Name: | Medical recirculating air cleaner. (per 21 CFR 880.5045) |
| Classification: | FDA has classified these devices in Class II. |
| | Panel: 80 |
| | Product Code: FRF |

#### Purpose of Submission

The purpose of this submission is to establish the substantial equivalence of a new device not previously marketed in the USA (Plasmair™ Model T2006) to devices previously cleared through the 510(k) process.

#### Substantial Equivalence

The new device is substantially equivalent to the Biological Controls, Inc, MICROCON 800MUV (K972064).

#### Technological Characteristics

The device uses spatially modulated, amplified multidirectional electrostatic field technology to create cold plasmas for decontamination and capture of airborne particulates. These technologies do not raise new questions of Safety or Effectiveness.

#### Performance Data

Electrical safety and performance data included in the submission established that the device meets the performance specifications.

#### Conclusion

Airinspace, BV concludes based on the information presented that the Plasmair™ Model T2006 is substantially equivalent to the current legally marketed products in the USA.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2007

AirInSpace B.V. C/O Mr. Wade Tetsuka Consultant Wade Tetsuka 43795 Lee Mill Square Leesburg, Virginia 20176

Re: K070722

Trade/Device Name: Plasmair " Model T2006 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: II Product Code: FRF Dated: November 21, 2007 Received: November 29, 2007

Dear Mr. Tetsuka:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Tetsuka

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu-Ling Lu, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number: K070722

Device Name: Plasmair™ Model T2006

The Plasmair Model T2006 is intended as a room air purifier/recirculating air Indications for Use: cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical cleaner. The System's dood for member of to supplement existing building air treatment and/or provide air treatment where none exists.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A Murphy, MD

Kotozzz

Prescription Use:

or

Over-the-Counter Use: X (Per 21 CFR 801.109)

- Confidential -